The Recall Desk

FDA (Devices) recall action 70917

Ortho-Clinical Diagnostics recalled 2 products on 2015-06-17

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-06-17
Critical
0
Units
—

Why these products were recalled

Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2015-06-17

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-06-17

    Ortho-Clinical VITROS 4600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Distribution
    0 states